Plus Therapeutics Announces FDA Agreement to Initiate ReSPECT-LM Dose Optimization Trial

PSTV
October 05, 2025

Plus Therapeutics, Inc. announced on June 30, 2025, the initiation of the ReSPECT-LM dose optimization trial for REYOBIQ™ (rhenium Re 186 obisbemeda). This trial is for the treatment of leptomeningeal metastases (LM).

The dose optimization trial follows encouraging results from the company’s single-dose escalation trial and is designed to evaluate multiple-dose regimens of REYOBIQ. The study design is consistent with the FDA’s Project Optimus, aiming to optimize treatment dosing for maximum efficacy and safety.

Primary objectives include determining the safety and tolerability of multiple REYOBIQ doses administered via intraventricular catheter at defined intervals, and identifying both the maximum tolerated dose and minimum effective dose. The trial benefits from a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT).

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